NDC 43353-098
Metformin Hydrochloride 1000 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-760.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyMar 24, 2023 · 5 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Product details
- Generic drug
- Metformin: every company that makes it
- Form
- tablet, film coated
- Strength
- 1000 mg
- Approval
- ANDA ANDA077064
- On the market since
- Dec 9, 2014
- Package NDCs
43353-098-6043353-098-80- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2019
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